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[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Notices]
[Pages 104547-104549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30502]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-52]

Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), Federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by February 21, 2025.

[[Page 104548]]

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-R-52 End Stage Renal Disease (ESRD) Conditions for Coverage and 
Supporting Regulations
CMS-10901 Expanding Access to Women's Health Grant

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collections

    1. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: End Stage Renal Disease (ESRD) Conditions for Coverage and 
Supporting Regulations; Use: The Centers for Medicare and Medicaid 
Services (CMS) is requesting reinstatement of OMB Control number 0938-
0386 (CMS-R-52) in compliance with the Paperwork Reduction Act (PRA). 
This package applies to existing Medicare End-stage Renal Disease 
(ESRD) conditions for coverage (CfCs) at 42 CFR 494. Section 299I of 
the Social Security Amendments of 1972 (Pub. L. 92-603) originally 
extended Medicare coverage to insured individuals, their spouses, and 
their dependent children with ESRD who require dialysis or 
transplantation. Subsequently, the ESRD Amendments of 1978 (Pub. L. 95-
292) amended title XVIII of the Social Security Act (the Act) by adding 
section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to 
prescribe health and safety requirements (known as conditions for 
coverage) that a facility providing dialysis and transplantation 
services to patients must meet to qualify for Medicare reimbursement. 
Final regulations were published June 3, 1976. Subsequent to the 
publication of the final regulations, the ESRD Amendments of 1978 were 
enacted to amend title XVIII of the Act to include section 1881(c). 
This section establishes ESRD network areas and Network organizations 
to assure the effective and efficient administration of ESRD program 
benefits. The requirements from section 1881(b) and (c) are implemented 
in regulations at 42 CFR part 405, subpart U, Conditions for Coverage 
for dialysis facilities.
    On April 7, 1986, the Consolidated Omnibus Budget Reconciliation 
Act of 1975 (COBRA) (Pub. L. 99-272) was enacted which requires the 
Secretary to maintain renal disease Network organizations as authorized 
under section 1881(c) of the Act, and not merge the Network 
organizations into other organizations or entities. On April 15, 1986, 
we published a notice of proposed rulemaking to implement section 9214 
of Public Law 99-272. A final rule (HSQ-115) was published August 26, 
1986 which included information collection requirements at Sec.  
405.2112(e). This rule revised the requirements in regulations 
pertaining to the ESRD networks and organizations and establishes new, 
more efficient Network organizations.
    Revisions resulting from two additional rules: HSQ-137--ESRD: 
Responsibilities of Network Organizations, published January 21, 1988; 
and BERC-434--Medicare Program: Standards for the Reuse of Hemodialyzer 
Filters and Other Dialysis Supplies, published October 2, 1987, are 
also included. HSQ-137-ESRD approved information collection 
requirements at Sec. Sec.  405.2112(f) and (j). BERC-434 approved 
information collection requirements stemming from the following 
historical sections of the CFR including Sec. Sec.  405.2136(b), 
405.2138(a), 405.2139(a), and 405.2140(b) and (c).
    Major revisions to the CFR established new ESRD CfCs at 42 CFR 494 
issued in a final rule, ``Medicare and Medicaid Programs; Conditions 
for Coverage for End-Stage Renal Disease Facilities,'' published on 
April 15, 2008 (CMS-3818-F). This rule modified, removed, added, and 
redesigned CfCs that dialysis facilities must meet to be certified 
under the Medicare program. This rule approved information collection 
requirements at Sec. Sec.  494.30, 494.40, 494.50, 494.60, 494.70, 
494.80, 494.90, 494.100, 494.110, 494.120, 494.150, 494.170, and 
494.180.
    An additional revision to the ESRD CfCs at 42 CFR 494 was 
precipitated by CMS-3818-F at 414.330(a)(2)(iii)(C). The burden to ESRD 
home dialysis suppliers associated with this requirement would be the 
time and effort necessary to collect all data for each patient 
receiving home dialysis care with respect to services and items 
furnished. However, the payment method that covered these suppliers was 
eliminated in 2011 and there are no longer any such entities. See 42 
CFR parts 410, 413 and 414 Medicare Program; End-Stage Renal Disease 
Prospective Payment System; Final Rule and Proposed Rule at the 
following link Federal Register https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf.
    Therefore, there are no actual costs associated with this 
requirement; we removed it from this package.
    An additional revision to the ESRD CfCs at 42 CFR part 494 was 
precipitated by interim final rule, ``Medicare Program; Conditions for 
Coverage for End-Stage Renal Disease Facilities-Third Party Payment,'' 
published on December 14, 2016 (CMS-3337-IFC). This rule established 
new requirements for Medicare-certified dialysis facilities that make 
payments of premiums for individual market health plans. This interim 
final rule

[[Page 104549]]

established additional burden associated with Sec. Sec.  494.70(c) and 
494.180(k); these were quantified in the preceding information 
collection which expired in 2024 (OMB Control Number 0938-0386). Since 
these regulations were not finalized due to litigation, they are no 
longer in effect. Therefore, we took out these sections from this 
package as they do not impose any burden.
    An additional revision to the ESRD CfCs at 42 CFR 494 was 
precipitated by final rule, ``Medicare and Medicaid Programs; Emergency 
Preparedness Requirements for Medicare and Medicaid Participating 
Providers and Suppliers,'' published September 16, 2016 (CMS-3178-F). 
This rule established the creation and maintenance of an Emergency 
Preparedness Plan at 494.62(a), an Emergency Preparedness Policies and 
Procedures document at 494.62(b), an Emergency Preparedness 
Communication Plan at 494.62(c), a training program 494.62(d), and 
documentation of training exercises 494.62(e). These information 
collections are in separate package, OMB Control number 0938-1325.
    On July 5, 2024, revisions to the CfC were proposed in ``Medicare 
Program; End-Stage Renal Disease Prospective Payment System, Payment 
for Renal Dialysis Services Furnished to Individuals with Acute Kidney 
Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, 
End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal 
Disease Treatment Choices Model'', (CMS-1805-P). This rule proposed to 
expand coverage of home dialysis services to patients with acute kidney 
injury (AKI). Since the ESRD CfCs apply to dialysis facilities, not to 
people with ESRD, this rule proposes to revise language in the CfCs to 
allow beneficiaries with AKI to utilize home dialysis. Specifically, we 
refer to facilities abiding by the ESRD CfCs as `dialysis facilities' 
opposed to `ESRD facilities and all patients seeking services from 
dialysis facilities as `patients' rather than `ESRD patients.' There is 
no ICR burden associated with these changes however we made confirming 
changes to the language in this package.
    The CfCs are used by Federal (CMS), State surveyors (employed by 
State survey agencies), or CMS authorized accrediting organizations as 
a basis for determining whether a dialysis facility qualifies for 
approval or re-approval under Medicare. Surveyors make an in-person 
visit to the dialysis facility to perform the complete survey.
    The preceding information collection, which expired on March 31, 
2024, estimated the total annual hourly burden as 1,260,491 hours at a 
cost of $64,839,657. We revise this to 800,621 hours at a cost of 
$49,638,502. The reduction in hours and cost is largely due to removing 
the burden estimates that no longer apply. Form Number: CMS-R-52 (OMB 
Control Number: 0938-0386); Frequency: Annually; Affected Public: 
Private sector--Business or other for-profit; Number of Respondents: 
8,048; Total Annual Responses: 215,591; Total Annual Hours: 800,621 
(For policy questions regarding this collection contact Claudia Molinar 
at 410-786-8445.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of information Collection: 
Expanding Access to Women's Health Grant; Use: On March 23, 2010, 
President Obama signed into law the Patient Protection and Affordable 
Care Act (PPACA), and on March 30, 2010, the Health Care and Education 
Reconciliation Act of 2010 was also signed into law (collectively 
referred to as the ``ACA''). The ACA includes a number of provisions 
that reform the health insurance markets and provide Federal consumer 
protections through amendments to title XXVII of the Public Health 
Service Act (PHS Act) and corresponding amendments to the Employee 
Retirement Income Security Act and the Internal Revenue Code. The ACA 
also includes significant grant funding for States to work with the 
Federal Government to implement the Federal market reforms and consumer 
protections.
    Section 1003 of the ACA adds a new section 2794 to the PHS Act 
entitled, ``Ensuring That Consumers Get Value for Their Dollars.'' 
Specifically, section 2794(a) requires the Secretary of the Department 
of Health and Human Services (the Secretary) (HHS), in conjunction with 
the States, to establish a process for the annual review of health 
insurance premiums to protect consumers from unreasonable rate 
increases. Section 2794(c) directs the Secretary to carry out a program 
to award grants to States. The data collection (quarterly and final 
reports) are a source of information on the State's progress with 
meeting CMS expectations for the Expanding Access to Women's Health 
Grant. The reports describe significant advancements towards the 
State's goal of enhancing and expanding access to reproductive and 
maternal health coverage and services from the beginning of the grant 
period through the completion of the grant period. The data collection 
is imperative to CMS being able to assess the State's progress, 
barriers, and updates on measurable objectives. Without the data 
collection, CMS will be unable to efficiently monitor the State's 
progress. It will also inhibit CMS' ability to support and share 
opportunities of best practices with other States. Form Number: CMS-
10901 (OMB control number 0938-NEW); Frequency: Quarterly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 15; 
Total Annual Responses: 68; Total Annual Hours: 840. (For policy 
questions regarding this collection contact Jim Taing at 
[email protected].)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-30502 Filed 12-20-24; 8:45 am]
BILLING CODE 4120-01-P
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